Human Research Ethics

Clinical trials in which registered or listed medicines (or medical devices) are used within the conditions of their marketing approval are not subject to CTN or CTX requirements but still need to be approved by a Human Research Ethics Committee (HREC) before the trial may commence. 

The increased awareness of ethical issues relating to human research has led to the release in 2002 of the Human Research Ethics Handbook, including detailed commentary on the national statement and discussion of ethical and legal issues, to further assist H RECs to assess and facilitate the ethical conduct of research involving human participants, and resolve the challenges encountered during this process. 

Acknowledgments The authors would like to thank all University of Sydney students who agreed to participate in this study. Data collections described in this work were authorised by the University of Sydney Human Research Ethics Committee, project reference numbers 04-2004/7353 and 08-2005/4/8461. 

Ethical approval for the 1998—1999 and 2000—2001 surveys was granted by the University of Tasmania Human Research Ethics Committee and for the post-intervention surveys in 2003, 2004, 2005 and 2007 by the Southern Tasmanian Health and Medical Human Research Ethics Committee and the Department of Educations Office of Educational Review. Individual informed consent was obtained from a patent/guardian of each child for all surveys. 

The study was approved by the University of Queensland Human Research Ethics Committee (reference 2011001430). 

The introduction of a product designed for implantation into humans requires a comprehensive development program, structured to address issues of potential toxicity, safety, and efficacy in vitro, followed by preclinical in vivo testing in appropriate animal models. Only after safety and efficacy are established, can human trials be considered. Since the employment of the NovoSorb biodegradable polyurethane platform was entirely novel in both material and concept, we followed this strategy. All trial proposals were submitted to, and approved by, the relevant Animal or Human Research Ethics Conunittee. 

Army Medical Research and Development Command Contract Review Board and the Surgeon General s Human Use Committee and Clinical Investigation Committee, to insure uniform application of ethical standards for human research studies conducted within or sponsored by the Army Medical Department and other Army Agencies. 

Over the years, scientific research with human subjects has provided valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. As an example, studies carried out for the authorization of a medical product, have to be conducted in line with the World Medical Association s Declaration of Helsinki, which describes the general ethical principles for medical research involving human subjects (World Medical Association 2004). The Helsinki Declaration was first issued by the World Medical Association in 1964 and has been revised several times since then. 

From this and other guidelines have developed current principles of good clinical practice ( GCP ) centred on ethical review by committee, with a favourable opinion being at least a moral precondition of the commencement of any human research project. In 1989, the CPMP (the Committee for Proprietary Medicinal Products) adopted GCP guidelines (based on a previous 1987 version) for the European Union. Although they were not in themselves legally enforceable, the pharmaceutical industry saw compliance with the guidelines... 

Attkisson, C.C., Rosenblatt, A., and Hoagwood, K. (1996) Research ethics and human subjects protection in child mental health services research and community studies. In Hoagyvood, K., Jensen, P.S., and Fisher, C.B., eds. Ethical Issues in Mental Health Research with Children and Adolescents. Mahwah, NJ Lawrence Erlbaum Associates, pp. 43-58. 

Human genomic research ethics changing the ruies... 

Current research ethics do not adequately address the issue of international research on the diversity of the human genome. Under current research standards, this research will widen the gap between developed and underdeveloped countries. New ethics standards for this research should frame this research so the market value of property rights from such research fosters the development of research institutions, a scientific workforce, and access to investment and venture capital within underdeveloped countries. The 1992 CBD offers just such a foundation. 

Kass, N.E. 2005. Research Ethics and Human Biomonitoring Research. Presentation at the Second Meeting on Human Biomonitoring of Environmental Toxicants, April 28, 2005, Washington, DC. 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

Many of the decisions to be made by the team, and particularly by the investigators, pose ethical dilemmas. Legislation has been enacted to protect human research subjects. Recently, the most pressing ethical dilemma facing the clinical research scientist concerned biotechnology and genetic engineering research. 

Legislation that ensures the protection of human research subjects in the United States includes the 1979 publication of the Belmont Report on the Ethical Principles and Guidelines for the Protection of Human Subjects of Research.f This report concerns the fine line between biomedical research and the routine practice of medicine and explores the criteria that determine the risk-benefit ratio in the consideration of conducting clinical research. It also addresses basic guidelines for the proper selection of human research subjects and further defines the elements of informed consent. 

Despite the principle of informed consent, ethical difficulties in human research remain. After all, when a new drug is developed, someone has to be the first person to take it. Even though federal law says that a drug must be tested extensively in animals before it is tried with people, some side effect not detected in the animal studies could still occur. 

Ethical questions must be addressed carefully in the administration of both active and inactive (placebos) drugs to human research participants. 

Code of Ethical Conduct for Research Involving Humans, Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, 1998. http //www. nserc.ca/programs/ethics/english/policy.htm. 

Research Ethics Guidance for Nurses Involved in Research or Any Investigative Project Involving Human Subjects, Royal College of Nursing Research Society, 1998. http //www.doh.gov.uk/ research/rd3/nhsrandd/researchgovemance/gov-home.htm. 

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